Antimicrobial Susceptibility for Helicobacter Pylori Eradication

Usefulness of Antimicrobial Susceptibility in the Eradication of Helicobacter Pylori

Due to the high rate of resistance to clarithromycin in our area the investigators proposed an study to assess the need of antibiogram previous to the empirical OCA 10 treatment, in order to improve the rate of eradication.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Other: OCA 10

Detailed Description

Usefulness of antimicrobial susceptibility in the eradication of Helicobacter pylori

PURPOSE

Background:

• The rate of eradication of Helicobacter pylori with standard triple therapy (OCA: omeprazole + clarithromycin + amoxicillin) in our area is less than the expected according to the III Maastricht III consensus. However, the current guidelines recommend the use of this therapy.
• According to the Maastricht III consensus, in populations with high rates of clarithromycin resistance (15-20%) another therapy should be considered, or alternatively, testing antimicrobial susceptibility of the H. pylori prior to treatment.

Objectives:

• To clarify the real rate of eradication with OCA therapy with and without antimicrobial susceptibility in our area (with high rate of resistance to clarythromycin).
• To study which is the diagnostic-therapeutic strategy more cost-effective for the treatment of H. pylori.

Design:

• Participants will be screened with a full medical history.
• Participants will aleatory receive OCA therapy empirically, or after antimicrobial susceptibility test if there is no resistance to clarythromycin, for ten days.
• In all cases the eradication of H. pylori will be checked by 13C urea breath test (UBT) in 8 weeks after the therapy have been finished.
• All the adverse event of the therapy will be reported.

• Study Type: Observational
• Enrollment (Anticipated): 1

Contacts and Locations

Study Locations

• Spain
  • Guipuzcoa
    • San Sebastian, Guipuzcoa, Spain, 20014
      • Recruiting
      • Hospital Donostia
      • Contact: LUIS BUJANDA, Dr; Phone Number: 943 007173; Email: luis.bujandafernandezdepierola@osakidetza.net
      • Contact: MAIDER MARTOS, Dr.; Phone Number: 943 00 7173; Email: maider.martosmartin@osakidetza.net
      • Principal Investigator: LUIS BUJANDA, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The investigators recruited patients who are diagnosed with helicobacter pylori infection in our hospital (Hospital Donostia) or in any of the specialist care centres under the management of the Hospital Donostia.

Description

Inclusion Criteria:

• Diagnosis of H. pylori infection provided by culture, histology or UBT.
• Patients need and indication to treat (peptic ulcer disease, firs-degree family history of gastric cancer, MALT lymphoma or dyspeptic symptoms)
• Patients must be 18 years or older.

Exclusion criteria:

• Previous treatment for H. pylori eradication.
• Patients who have severe concomitant disease.
• Patients who have previous gastric surgery.
• Patients who have intolerance to any antimicrobial drugs.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Empirical OCA; This group will be treated with omeprazole, amoxicillin and clarithromycin without having a previous antibiogram.	Other: OCA 10; A group will be treated with omeprazole (20 mg / 12 h), amoxicillin (1 g/ 12 h)and clarithromycin (500 mg/12 h) for 10 days (as following current guides) without having a previous antibiogram, and the other group will be treated after antibiotic susceptibility.; Other Names: O: Omeprazole; C: Clarithromycin; A: Amoxicillin
OCA after antibiogram; This group will be treated with omeprazole, clarithromycin and amoxicillin after an antibiotic susceptibility confirmation.	Other: OCA 10; A group will be treated with omeprazole (20 mg / 12 h), amoxicillin (1 g/ 12 h)and clarithromycin (500 mg/12 h) for 10 days (as following current guides) without having a previous antibiogram, and the other group will be treated after antibiotic susceptibility.; Other Names: O: Omeprazole; C: Clarithromycin; A: Amoxicillin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients in whom Helicobacter pylori was eradicated.	The investigators will measure the rate of eradication in each gruop after OCA treatment. One group receive OCA without antibiogram and the other one after checking the sensitivity to clarithromycin.	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patient with adverse event	9 months
Cost of the eradication of Helicobacter Pylori in each group.	9 months

Collaborators and Investigators

• Sponsor: Hospital Donostia
• Investigators: Study Director: LUIS BUJANDA

Publications and helpful links

General Publications

• Martos M, Bujanda L, Salicio Y, Sarasqueta C, Ibarra B, Mendarte U, Fernandez-Reyes M, Cosme A. Clarithromycin for first-line treatment of Helicobacter pylori infection after culture in high-resistance regions. Eur J Gastroenterol Hepatol. 2014 Dec;26(12):1380-4. doi: 10.1097/MEG.0000000000000197.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Anticipated): May 1, 2012

Study Registration Dates

• First Submitted: November 19, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (Estimate): December 6, 2011

Study Record Updates

• Last Update Posted (Estimate): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 11, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Eradication; Antibiogram; OCA 10
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Amoxicillin; Clarithromycin; Omeprazole
• Other Study ID Numbers: HP02